BIO 79-ACL4-2020

GUDID D78879ACL420200

BIO CU FORM A 20X20 L2 T2

Gc Orthodontics America Inc.

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire

• Primary Device ID: D78879ACL420200
• NIH Device Record Key: d3daac46-81e3-4819-8844-74c61b7d5cf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO
• Version Model Number: 79-ACL4-2020
• Catalog Number: 79-ACL4-2020
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78879ACL420200 [Unit of Use]
HIBCC	D78879ACL420201 [Primary]

FDA Product Code

• DZC: WIRE, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-16
• Device Publish Date: 2020-09-08

Devices Manufactured by Gc Orthodontics America Inc.

• D78811201CC511201 - EXPERIENCE: 2023-04-07 EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345
• D78811202AA597521 - EXPERIENCE: 2023-04-07 EXPC CCO U5-5 EXPM MBT L5-5 022 hks345
• D78812202AA519151 - EXPERIENCE: 2023-04-07 EXCM U5-5 EXPM L5-5 MBT 022 HK345
• D788122C0500101 - EXPERIENCE: 2023-04-07 EXMC ROTH 022 U5-5 HK 345
• D788151CC5S0101 - CHIC: 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5
• D788152CC5S0101 - CHIC: 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5
• D788312BB5GP201 - LEGEND: 2023-04-07 LMI GOLD MBT 022 U/L 6-6 HK 345
• D788312CC542191 - LEGEND: 2023-04-07 LMI ROTH U 2-2 MBT 345 HK 345